Longitudinal Clinical Evaluation of the HPV Assay on the BD VIPER LT System With Cervical Specimens
1 other identifier
observational
6,730
2 countries
40
Brief Summary
The purpose of the study is to assess the cumulative disease detection of greater than or equal to Cervical intraepithelial neoplasia 2 (CIN2) and greater than or equal to Cervical intraepithelial neoplasia 3 (CIN3) in the subjects over 3 years using the subject's HPV status and cytology status from the BDS-USHPV baseline results
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2014
Longer than P75 for all trials
40 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2014
CompletedFirst Submitted
Initial submission to the registry
October 14, 2014
CompletedFirst Posted
Study publicly available on registry
October 20, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 12, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2019
CompletedFebruary 8, 2021
February 1, 2021
4.2 years
October 14, 2014
February 4, 2021
Conditions
Outcome Measures
Primary Outcomes (3)
Cumulative risk of Cervical Intraepithelial Neoplasia 2 and 3 (CIN2 and CIN3) over three years in Human Papillomavirus (HPV) Positive Patients.
Cumulative risk is a measure of the total risk that a certain event will happen during a given period of time. In this longitudinal study, it refers to the risk of developing \>=CIN2 or \>=CIN3 in subjects over a three year period using the subjects' HPV status at baseline versus cytology status at baseline.
3 years
Absolute Risk of Cervical Intraepithelial Neoplasia 2 and 3 (CIN2 and CIN3) over 3 years in Human Papillovirus (HPV) Positive Patients.
Absolute risk will be calculated as: (number of disease cases)/(number of patients at risk).
3 years
To evaluate different screening strategies using Human Papillovirus (HPV) results with 16/18/45 genotyping and cytology.
The sensitivity and specificity of HPV primary screening algorithms for identifying ≥ CIN2 and ≥ CIN3 using genotyping and cytology will be calculated.
3 years
Secondary Outcomes (3)
Cumulative Risk of Cervical Intraepithelial Neoplasia 2 and 3 (CIN2 and CIN3) over 3 years in NILM (Negative for Intraepithelial lesion or malignancy) cytology and Human Papillovirus (HPV) Negative Patients.
3 years
Absolute Risk of Cervical Intraepithelial Neoplasia 2 and 3 (CIN2 and CIN3) over 3 years in NILM (Negative for Intraepithelial Lesion or Malignancy) cytology and Human Papillomavirus (HPV) Negative Patients.
3 years
Evaluate Different Screening Strategies Using HPV Results with Genotyping (other than 16/18/45) and Cytology.
3 years
Study Arms (1)
BD VIPER LT
Interventions
The BD HPV specimen will be tested with the BD HPV Assay on the Viper LT instrument.
The colposcopy will be performed on subjects that have abnormal cytology. At the third year visit all subjects will have an exit colposcopy.
Eligibility Criteria
Participants were selected from a baseline study BDS-USHPV, which included female healthy volunteers.
You may qualify if:
- Subject enrolled into the protocol BDS-USHPV and identified as eligible for the longitudinal protocol • Subjects enrolled into protocol BDS-USHPV with a baseline colposcopy and biopsy procedure and not treated.
You may not qualify if:
- Subjects with prior complete or partial hysterectomy involving removal of the cervix
- Subjects on whom conization, LEEP, cervical laser surgery, or cryosurgery has been performed since enrollment into the BDS-USHPV study
- Year 3 visit can not exceed 3 years and 6 months from the baseline visit
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (40)
University of Alabama
Birmingham, Alabama, 35294, United States
Mobile OB/GYN
Mobile, Alabama, 36608, United States
Women's Health Research of Arizona
Phoenix, Arizona, 85015, United States
Quality of Life Medical & Research Center
Tucson, Arizona, 85712, United States
Visions Clinical Research
Tucson, Arizona, 85712, United States
Women's Health Care Research Corp.
San Diego, California, 92123, United States
Blueskies Center for Women
Colorado Springs, Colorado, 80910, United States
Health Awareness Inc.
Jupiter, Florida, 33458, United States
Altus Research
Lake Worth, Florida, 33461, United States
Segal Institute for Clinical Research
North Miami, Florida, 33161, United States
Miami Research Associates
South Miami, Florida, 33143, United States
Comprehensive Clinical Trails, LLC
West Palm Beach, Florida, 33409, United States
Medical Network for Education & Research
Decatur, Georgia, 30033, United States
Fellows Research Alliance - Savannah
Savannah, Georgia, 31406, United States
Women's Health Practice
Champaign, Illinois, 61820, United States
Indiana University
Indianapolis, Indiana, 46202, United States
Four Rivers Clinical Research
Paducah, Kentucky, 42003, United States
Louisiana State University
New Orleans, Louisiana, 70112, United States
BD 54 Loveton
Sparks, Maryland, 21152, United States
Saginaw Valley Medical Research
Saginaw, Michigan, 48604, United States
Virtua Phoenix OB/GYN
Moorestown, New Jersey, 08057, United States
Meridian Health / Jersey Shore University Medical Center
Neptune City, New Jersey, 07753, United States
Quest Laboratories
Teterboro, New Jersey, 07608, United States
TriCore
Albuquerque, New Mexico, 87102, United States
Research Pathology Associates, LLC
Irvington, New York, 10533, United States
Montefiore Medical Center
The Bronx, New York, 10461, United States
Eastern Carolina Women's Center
New Bern, North Carolina, 28562, United States
Lyndhurst Clinical Research
Winston-Salem, North Carolina, 27103, United States
HWC Women's Research Center
Englewood, Ohio, 45322, United States
Center for Women's Health of Lansdale
Lansdale, Pennsylvania, 19446, United States
Clinical Research of Philadelphia
Philadelphia, Pennsylvania, 19114, United States
Reading Health Physician Network
West Reading, Pennsylvania, 19611, United States
Fellows Research Alliance - Bluffton
Bluffton, South Carolina, 29910, United States
James T. Martin Jr. OB/GYN
North Charleston, South Carolina, 29406, United States
Chattanooga Medical Research
Chattanooga, Tennessee, 37404, United States
Center for Disease Detection, LLC
San Antonio, Texas, 78233, United States
Physicians Research Options
Draper, Utah, 84020, United States
Research Pathology Associates
Charlottesville, Virginia, 22901, United States
Tidewater Clinical Research
Virginia Beach, Virginia, 23462, United States
BioVision
Montreal, Quebec, H2V3J1, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Tobi Karchmer, MD
Becton, Dickinson and Company
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 14, 2014
First Posted
October 20, 2014
Study Start
October 1, 2014
Primary Completion
December 12, 2018
Study Completion
May 1, 2019
Last Updated
February 8, 2021
Record last verified: 2021-02